Setback for Abbott's Mitraclip Heart Device

By

Jennifer Corbett Dooren

March 18, 2013 12:51 p.m. ET

WASHINGTON—The U.S. Food and Drug Administration recommended against approval of Abbott Laboratories' Mitraclip heart device, saying there isn't currently enough evidence to show the product is safe and effective.

Abbott is seeking FDA approval of Mitraclip, which is designed to fix leaky heart valves in patients who aren't considered good...